MAUDE Adverse Event Report: CONMED LARGO 1.5 X 10MM SIDECUTTING BUR, MEDIUM, STRAIGHT, 5 EA; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	5091-202
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
International complaints reported on behalf of the customer that the device, 00509120200, 1.5 x 10mm sidecutting bur, medium, straight 1256148, was being used on (b)(6) 2023 during a bilateral osteotomy procedure when it was reported ¿drills (2 units) broke during procedure one drill bit not found awaiting xray to confirm location is not in the patient.¿ further assessment questioning found that ¿while performing a bilateral osteotomy, two conmed 00509120200 side cutting burs broke.The surgical team were able to retrieve the broken part from the first bur.However, the surgical team were not able to find the part that broke on the second bur.The surgical site was investigated but nothing could be found, it was assumed the broken piece got sucked up in the suction.The surgical site access was reported as being quite difficult.This report is being raised due to two burs breaking consecutively.Post operative orthopantomogram was conducted, the drill bit tip was not found on imaging.No patient injury reported¿.The first drill bit was retrieved with the use of artery forceps.The second drill bit was not retrieved but confirmed by opg xray that the fragment was not left in the patient.The procedure was completed with a 5¿10-minute delay and the current status of the patient was reported as ¿patient was fine and sent home.¿ there was no report of injury, medical intervention, or hospitalization for the patient.There were two lot numbers used in this procedure, lot number 1237750 & lot number 1256148.It is unknown which lot number was not able to be found.The 00509120200, 1.5 x 10mm sidecutting bur, medium,straight lot number 1237750 will be listed as a concomitant device.This report is being raised on the basis of injury due to fragmentation, although not found in the patient via x-ray, they cannot produce the piece and its location is unknown.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 12 complaints, regarding 14 devices, for this device family and failure mode.During this same time frame 436,035 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.00003.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
International complaints reported on behalf of the customer that the device, 00509120200, 1.5 x 10mm sidecutting bur, medium, straight 1256148, was being used on 01feb23 during a bilateral osteotomy procedure when it was reported ¿drills (2 units) broke during procedure one drill bit not found awaiting xray to confirm location is not in the patient.¿ further assessment questioning found that ¿while performing a bilateral osteotomy, two conmed 00509120200 side cutting burs broke.The surgical team were able to retrieve the broken part from the first bur.However, the surgical team were not able to find the part that broke on the second bur.The surgical site was investigated but nothing could be found, it was assumed the broken piece got sucked up in the suction.The surgical site access was reported as being quite difficult.This report is being raised due to two burs breaking consecutively.Post operative orthopantomogram was conducted, the drill bit tip was not found on imaging.No patient injury reported¿.The first drill bit was retrieved with the use of artery forceps.The second drill bit was not retrieved but confirmed by opg xray that the fragment was not left in the patient.The procedure was completed with a 5¿10-minute delay and the current status of the patient was reported as ¿patient was fine and sent home.¿ there was no report of injury, medical intervention, or hospitalization for the patient.There were two lot numbers used in this procedure, lot number 1237750 & lot number 1256148.It is unknown which lot number was not able to be found.The 00509120200, 1.5 x 10mm sidecutting bur, medium,straight lot number 1237750 will be listed as a concomitant device.This report is being raised on the basis of injury due to fragmentation, although not found in the patient via x-ray, they cannot produce the piece and its location is unknown.

• Brand Name: 1.5 X 10MM SIDECUTTING BUR, MEDIUM, STRAIGHT, 5 EA
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16444486
• Report Number: 1017294-2023-00014
• Device Sequence Number: 5860565
• Product Code: GFF
• UDI-Device Identifier: 10845854008409
• UDI-Public: (01)10845854008409(17)270712(30)1(10)1256148
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5091-202
• Device Catalogue Number: 00509120200
• Device Lot Number: 1256148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 00509120200, 1.5 X 10MM SIDECUTTING BUR; 00509120200, 1.5 X 10MM SIDECUTTING BUR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic